There is a clinical need for non-invasive neurologic monitoring in the intensive care unit (ICU), Emergency Department (ED), operating room (OR), battlefield, and pre-hospital settings. Currently, clinicians can assess the neurologic status of a patient by either performing a clinical neurological exam or through imaging of the central nervous system (CNS) using computed tomography (CT) or magnetic resonance imaging (MRI). Further, there exists a need for a non-invasive test of neurologic status that can alert the treating clinician to significant changes in the CNS status of the patient, such as hemorrhage, increase in intracranial pressure, cerebral edema or seizure.
Detecting bleeding in the brain from trauma or stroke is an important piece of diagnostic information. The sooner this information can be obtained by emergency medical technicians, paramedics, emergency room physicians, or intensive care physicians, the better the care for the head-injured patient. For ambulance personnel, knowing if a patient has a brain bleed will aid greatly in directing a patient's transport to a hospital with a trauma team and/or brain surgeon.
Currently, there are no active monitoring devices used for monitoring the brain changes transcranially. Current state-of-the-art and cutting edge technologies focus on highly specialized techniques such as electroencephalography (EEG), magnetoencephalography (MEG) and electrical impedance tomograpy (EIT). As described in more detail below, embodiments of the present disclosure measure and analyze changes made to the active signal resulting from propagation through the biological tissue, which is a new approach that has not previously been explored in the art.
Accordingly, a need exists for non-invasive neurologic monitoring of biological tissue, such as a human brain, that does not require interpretation by a trained technician, and may be deployed in a wide variety of settings, such as emergency rooms, ambulance vehicles, health care facilities, nursing care facilities, and the like.